XPulser DEEP Sleep AME Tuner study

Principle Investigator: William Pawluk, MD, MSc

Research Assistant: Phoebe Cole, PA

Study Sponsor: Health Energy Partners LLC

STUDY CONSENT FORM

Goal of the Study

The purpose of this Study is to evaluate the use of a home-based, nighttime, medium intensity PEMF audio magnetic entrainment (AME) stimulation device, to facilitate faster, deeper, longer and more satisfying sleep.

Procedures of the Study

Not everyone will be eligible for the Study. It will only be open to a limited number of people. Various sleep evaluation forms will have to be completed: a consultation health questionnaire and Study participation and consent forms signed. These will be reviewed and eligibility for the Study will be determined. Those meeting the criteria for participation will be provided with a formal invitation to the Study along with the needed Study equipment and materials.

Those who are not accepted or invited into the Study will receive the opportunity to purchase the XPulser DEEP Sleep AME Tuner at a discount

*** Please be sure to complete the Study participation consent form below.

Participants will go through two phases during the 5 weeks of the Study:

Phase 1, the control phase; one week – complete the sleep outcome questionnaire sent from OUTCOME MD and the daily sleep diary.

Phase 2, use the DEEP Sleep Tuner AME device, on the top pillow, per instructions, from the time of going to bed through the whole night, until getting out of bed for the day, every day for 4 more weeks. The AME device will continue to be placed on the pillow inside the pillow cover all night until getting up in the morning. Keep it on the pillow all night even if there is a need to get up during the night, resuming use when returning to bed. Continue to complete the sleep survey questionnaires sent from OUTCOMEMD and complete the daily sleep diary on getting up every day in the morning for the 4 weeks of this phase of the Study.

Inclusion criteria

Anyone with sleep issues who does not meet the exclusion criteria and would agree to use the Xpulser DEEP Sleep AME Tuner and complete all the necessary documentation required.

Study participants will be invited from an email list from drpawluk.com and be accepted as a convenience sample, on a first-come first-served basis.After fill